Development and Implementation of a Practical Training and Assessment System for LC‒MS/MS Sample Preparation in Clinical Laboratory Medicine: A feasibility Study

Abstract

 Background: Liquid chromatography‒tandem mass spectrometry (LC‒MS/MS) is indispensable in clinical laboratories, yet standardized and effective training programs for short-term rotating trainees in clinical laboratory medicine remain underdeveloped.

Objectives: To develop and evaluate a standardized competency-based on-the-job training (OJT) system for LC‒MS/MS sample preparation, incorporating quantitative performance metrics to objectively assess trainee competency.

Methods: This study enrolled 43 participants, including 11 undergraduates, 13 postgraduates, and 19 continuing medical education (CME) specialists. Participants completed pipetting proficiency test and hands-on training for voriconazole and antipsychotic drug sample preparation. Competency was assessed using intraindividual variation (IIV) and bias derived from internal standard (IS) response data, with predefined thresholds. Troubleshooting discussion and feedback survey were conducted immediately after the training.

Results: Trainees exhibited superior pipetting accuracy and precision for water versus organic solvents (dichloromethane). Postgraduates outperformed undergraduates and CME specialists in terms of the precision of sample preparation, particularly for antipsychotic drugs. The training system achieved high satisfaction rates:  74.4% reported increased interest in LC‒MS/MS technology, 97.7% acknowledged improved hands-on skills, and 86.1% perceived no added rotation burden. Further troubleshooting revealed that organic solvent handling, supernatant transfer consistency and prior experience were the main factors affecting the trainees’ LC‒MS/MS sample preparation performance.

Conclusion: This study establishes the first OJT system for LC-MS/MS that links quantitative metrics to hands-on competency, addressing a critical practical training gap for short-term rotations in clinical laboratory medicine. The framework’s adaptability and trainee-centric design offer a scalable model for standardizing skill assessment in clinical laboratories, with potential applications to other complex techniques.